A randomized controlled study of roxatidine in the prevention of stress related mucosal disease / 中华急诊医学杂志

ABSTRACT

Objective:To evaluate the efficacy of roxatidine and omeprazolein on preventing gastrointestinal bleeding in critically ill patients.Methods:A prospective cohort study was conducted in adult patients admitted to an intensive care unit (ICU), who had risk factors for stress related mucosal disease (SRMD), and had an estimated stay of no less than 5 days and mechanical ventilation for more than 48 h. Patients were randomized into the experiment group (Roxatidine 75 mg IV Q12 h) and control group (Omeprazole 40 mg IV Q12 h). Demographic data, acute physiology and chronic health score (APACHEⅡ) and SOFA score on day 1 were collected, intragastric pH values were tested every 2 hours for the first 5 days, the daily average of pH and proportion of patients with average pH≥4 were calculated. Stool occult blood were detected at day 1 and bacterial culture of gastric juice were performed before medication administration and on day 5 after medication administration. The implementation of enteral nutrition support, situation of gastrointestinal hemorrhage and adverse effects were analyzed. Furthermore, length of hospital stay and mortality in ICU and on the 28th day were acquired. SPSS 22.0 software was used for data analysis. Consecutive data were expressed as mean and standard deviation, categorical data were expressed as frequencies (percentage). Comparison of measurement data between groups was performed by analysis of variance or rank sum test. Comparison of count data between groups was performed by the Chi-square test. P<0.05 was regarded as statistically significant. Results:A total of 91 patients were recruited and randomly separated into experimental group ( n=46) and control group ( n=45) from October 2017 to March 2018. There were no statistical differences in gender, age, body mass index (BMI), enteral nutrition status, APACHEⅡ and SOFA score on day 1 between the two groups (all P>0.05). Roxatidine in the experiment group rapidly increased the intragastric pH to ≥4.0 and continued to stabilize at pH ≥4.0 during the monitoring period. Omeprazole increased and maintained intragastric pH≥5.0. The proportion of patients with average pH≥4.0 was 82.5% in the second 24 hours in the experiment group, and stably increased to 90% on day 5. There were no significant differences between groups in gastrointestinal bleeding, length of hospital stay, and mortality in ICU and on 28th day(all P> 0.05). No drug related adverse effects occurred during the study period. Logistic-regression analysis did not screen for risk factors of SRMD. Conclusions:Roxatidine acetate hydrochloride can rapidly elevate and maintain the gastric pH above 4.0, and has similar efficacy and safety as omeprazole in inhibiting gastric acid secretion and preventing SRMD with gastrointestinal bleeding.